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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INS SIZE4 16MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INS SIZE4 16MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5531G416
Device Problem Insufficient Information (3190)
Patient Problems Wound Dehiscence (1154); Bone Fracture(s) (1870); Unspecified Infection (1930); Damage to Ligament(s) (1952); Impaired Healing (2378)
Event Date 11/04/2014
Event Type  Injury  
Manufacturer Narrative

The following other devices were also listed in this report: antibiotic simplex p bone cement; cat# unknown; lot# unknown, triathlon universal tibial baseplate; cat# unknown; lot# unknown, triathlon tibial augment half block; cat# unknown; lot# unknown, triathlon offset adapter; cat# unknown; lot# unknown, triathlon fluted stem; cat# unknown; lot# unknown, it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience. The information in this report was provided by stryker orthopaedics legal affairs department. No additional information is available at this time. The device is not available due to the ongoing litigation. Should device or additional information become available, the evaluation summary will be submitted in a supplemental report. Not returned to the manufacturer.

 
Event Description

It is alleged that on (b)(6) 2014, the patient was returned to the or for " surgical repair of the patellar tendon, irrigation and debridement and ordered cultures with a postop diagnosis "early postoperative infection/wound drainage with failure to heal skin margins with rupture of extensor mechanism/patellar tendon. ".

 
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Brand NameX3 TRIATHLON CS INS SIZE4 16MM
Type of DevicePROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-LIMERICK
raheen business park
limerick NA
Manufacturer Contact
timothy rice
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5293606
MDR Text Key33404315
Report Number0002249697-2015-04230
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK141056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/04/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/14/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/13/2019
Device Catalogue Number5531G416
Device LOT NumberLDX564
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/05/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/13/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/14/2015 Patient Sequence Number: 1
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